Purpose of consultancy

The Laboratory Services and Networks (LNS) Team of the Regulation and Prequalification Department will be introducing a Laboratory Information Management System (LIMS) to streamline its areas of work relating to vaccines testing and quality control as part of the prequalification activities for vaccines. More specifically the LIMS will capture WHO independent testing through laboratory testing of vaccines by WHO-contracted national control laboratories (NCLs) as well as the collection and analysis of reported data from Official Control Authority Batch Release (OCABR) results of NCL’s. Furthermore, to record WHO customer audits of the contracted testing laboratories. The deliverables will be planned in several phases, including in 2022 the design/customization, development and building of the LIMS, the validation of the system prior to implementation. In the second half of 2022 and 2023, anticipated work relates to the further implementation of the system and updating the system with legacy documents.

Background

The establishment of a centralized electronic system for monitoring, tracking and accountability, managed by WHO, will enhance and facilitate the processes of WHO’s Laboratory Network and Services (LNS) independent vaccine testing programme, ensuring the quality of vaccines purchased by UNICEF, the Pan American Health Organization, Revolving Fund, GAVI and other agencies, by meeting WHO quality standards.

To increase the efficiency of the overall WHO prequalification programme an IT solution called ePQS was developed covering most aspects of the programme. However, it was decided that a custom-made IT solution better adapted to the LNS specific needs, would be a more functionally useful tool. Specifications and system requirements (matrix) were developed, and an international tender was organized to identify the most suitable LIMS software provider. The LIMS provider will work very closely with LNS staff and the consultant(s) in the design/customization, planning, installation, and implementation phase of the LIMS to ensure all specifications and system requirements are met.

Deliverables

Part I

Deliverable 1: Design/customization and development of the LIMS
Expected by: 1 June 2022

  • To provide answers to questions of the LIMS IT-provider on data, methods, processes, business needs, must-haves versus nice -to-haves.
  • Provide technical guidance on the process flowcharts, and specific information that need to be captured in the LIMS system into a logical format, the different record types, including e.g., information fields that need to be present on the various record types, the interaction between the record types, requirements for analytical functions etc. to the LIMS provider.
  • This design/customization and development phase will be iterative, running in several cycles, require extensive communication and feedback to the LIMS provider following installation of the LIMS modules.
  • All proposed solutions need to be tested and feedback provided on the system as it is customized and further developed.

Deliverable 2: Preparation of the validation datasets, migration and testing of the system
Expected by: 1 September 2022

  • Compile selected datasets for the various record types needs to be captured in the system in a logical format that can be passed on to the LIMS provider for their use.
  • Prepare the datasets to facilitate migration into the system.
  • Test and provide feedback on the system related to data migration.
  • Verify the accuracy of the information moved into the new system.
  • Participate in the testing of the system to ensure that it meets the requirements and is essentially bug free. After this step, migration of legacy documents can start.

Deliverable 3: Contribute to the development of a user guide and with training of users
Expected by: 15 December 2022

  • Contribute to the development of a user guide/user instructions.
  • Collaborate with the LIMS provider with the roll out of training of potential users and user adoption.
  • Provide training and support to different users, including internal users and a selection of external users, e.g. representatives from WHO-contracted national control laboratories and vaccine manufacturers. Revise the user guide according to the comments received.

Part II

Deliverable 4: Facilitate the migration of legacy documents and final system adjustments
Expected by: 30 April 2023

  • Facilitate, support and monitor the further migration of legacy documents into the new system. Provide guidance and support to external and internal users with the migration of legacy documents, as required.
  • Verify that the system is functional and feedback from all users (including external users, i.e. WHO contract laboratories and manufacturers of prequalified vaccines) is approved by WHO.
  • Provide final consolidated feedback to the LIMS provider and verify that final adjustments are implemented as agreed.

Qualifications, experience, skills and languages

Educational Qualifications:

Essential:
An advanced university degree (Masters level or above) in Biology, Pharmacy, Chemistry, Biochemistry, Microbiology, Medicine or related sciences

Experience

Essential:

  • Over 10 years of relevant professional experience in the field of regulation of biological products and expert knowledge in production/control/quality assurance of vaccines and biologicals acquired by working with a National Regulatory Authority, vaccine manufacturer or other relevant institutions such as Foundations and Associations.
  • Work experience with laboratory information management systems.

Desirable:
Work experience with the UN

Skills/Knowledge:

  • Scientific background and expertise, particular in the area of infectious diseases and vaccines. Extensive Knowledge of production and quality control of vaccines.
  • Expert knowledge of standard ISO 17025 (General requirements for the competence of testing and calibration laboratories).
  • Understanding of Good Manufacturing Practices and of quality management systems.
  • Ability to work in a highly political international environment.
  • Ability to manage a project.
  • Expertise in the establishment and requirements of a laboratory management system
  • Knowledge of electronic information management applications such as databases and SharePoint.
  • Computer proficiency intermediate level or above, particularly Microsoft program.
  • Demonstrated high level of both professional and technical expertise to assure credibility in the interactions and communications performed.

Languages required:

Essential:

Expert knowledge of English

Location

Home based – Off-site.

Travel

The consultant is not expected to travel.

Remuneration and budget (travel costs are excluded):

Remuneration:

Band level C - USD 10,000 - 12,500 per month. The renumeration will depend on the individual contracts and on the complexity of the tasks, following WHO policy on renumeration

Living expenses (A living expense is payable to on-site consultants who are internationally recruited):

N/A

Expected duration of contract:

The work will be conducted in two parts:
Part I 8.5 months (percentage FTE to be determined)
Part II 3.5 months (percentage FTE to be determined)

Additional Information

  • This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
  • Only candidates under serious consideration will be contacted.
  • A written test may be used as a form of screening.
  • If your candidature is retained for interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/. Some professional certificates may not appear in the WHED and will require individual review.
  • For information on WHO's operations please visit: http://www.who.int.
  • WHO is committed to workforce diversity.
  • WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
  • Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.
  • WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter into practice.
  • WHO has zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct. To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of final candidates.
  • Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority. The execution of the work under a consultant contract does not create an employer/employee relationship between WHO and the Consultant.
  • WHO shall have no responsibility whatsoever for any taxes, duties, social security contributions or other contributions payable by the Consultant. The Consultant shall be solely responsible for withholding and paying any taxes, duties, social security contributions and any other contributions which are applicable to the Consultant in in each location/jurisdiction in which the work hereunder is performed, and the Consultant shall not be entitled to any reimbursement thereof by WHO.
  • Consultants working in Switzerland must register with the applicable Swiss cantonal tax authorities and social security authorities, within the prescribed timeframes (Guidelines issued by the Swiss Mission are available at: https://www.eda.admin.ch/missions/mission-onu-geneve/en/home/manual-regime-privileges-and-immunities/introduction/Manuel-personnes-sans-privileges-et-immunites-carte-H/Non fonctionnaires et stagiaires.html
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